Central Information Commission
Pramod Kumar Gupta vs Ministry Of Health & Family Welfare on 25 November, 2019
के ीय सूचना आयोग
Central Information Commission
बाबा गंगनाथ माग, मुिनरका
Baba Gangnath Marg, Munirka
नई द ली, New Delhi - 110067
ि तीय अपील सं या / Second Appeal No.:- CIC/MH&FW/A/2018/131153-BJ
Dr. Pramod Kumar Gupta
....अपीलकता/Appellant
VERSUS
बनाम
1. CPIO
Under Secretary, Drugs Regulation Section
Ministry of Health & Family Welfare
Nirman Bhawan, New Delhi - 110011
2. CPIO
Assistant Drugs Controller (I)
Directorate General of Health Services
Office of DCG (I), RTI Cell, FDA Bhawan
Kotla Road, New Delhi - 110002
... ितवादीगण /Respondent
Date of Hearing : 19.11.2019
Date of Decision : 25.11.2019
Date of RTI application 12.03.2018
CPIO's response 23.03.2018/
09.05.2018
Date of the First Appeal 19.04.2018
First Appellate Authority's response Not on Record
Date of diarised receipt of Appeal by the Commission 16.05.2018
ORDER
FACTS:
The Appellant vide his RTI application sought information on 04 points regarding the copy of committee report submitted on 19.02.2018, constituted by MoH&FW to examine the issues relating to faulty ASR Hip Implants manufactured by M/s DePuy International Limited, U.K.; whether the report addresses the concern of affected patients who have been implanted with ASR, faced unfortunate medical conditions; steps taken by the Government for speedy action on the recommendations, etc. Page 1 of 7 The Assistant Drugs Controller (I) & CPIO, Directorate General of Health Services, vide its letter dated 23.03.2018, transferred the RTI application to the CPIO, MoH&FW, with a request to furnish the available information, if any, directly to the Appellant. Dissatisfied due to non- receipt of any response from the concerned CPIO, the Appellant approached the FAA. The FAA, Directorate General of Health Services, Office of DCG (I), vide its letter dated 09.05.2018, transferred the RTI Appeal to the FAA, Drug Regulation Section, MoH&FW. The reply of the CPIO/ order of the FAA, if any, is not on the record of the Commission.
HEARING:
Facts emerging during the hearing:
The following were present:
Appellant: Dr. Pramod Kumar Gupta;
Respondent: Mr. R. G. Singh, US (Drugs Regulation), Dr. R. K. Sharma, Dy. Drugs Controller and Mr. Abhishek Chawardol, DI;
The Appellant reiterated the contents of the RTI application and stated that the information sought had not been satisfactorily responded by the Public Authority. He had requested for panel recommendation of the committee constituted under the Chairmanship of Dr. Arun Kumar Agarwal to examine the issues relating to faulty ASR Hip Implants manufactured by M/s DePuy International Limited, U.K. Moreover, this implant caused worldwide several disabilities and later on withdrawn from the market. This caused severe reactions and disabilities to Hip Implant patients. In its reply, the Respondent reiterated the response of the CPIO/FAA and further relied on its written submission. The Respondent, MoH&FW, vide its written submission dated 13.11.2019 submitted that the Appellant had sought for a copy of report submitted by the Committee constituted vide order dated 08.02.2017 under the Chairmanship of Dr. Arun Kumar Agarwal, Ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi, to examine the issues relating to faulty ASR Hip Implants manufactured by M/s DePuy International Limited, U.K. The request was considered and it was found that the Committee had submitted its report which was under examination. Hence, attention of the Applicant was invited to Section 8(1) (i) of the RTI Act, 2005 vide which records of deliberations of officers are exempted from disclosure. Accordingly, a reply was sent to Dr. Gupta vide letter dated 04.05.2018. The Appeal of the Appellant was also considered by the FAA and Director who after such consideration upheld the reply dated 04.05.2018 sent by the CPIO. Accordingly, the Appeal was disposed of and the same was communicated to the Appellant vide order dated 28.06.2018.
Furthermore, it was informed that the said report which had been under examination (till the Appeal was disposed of) was accepted with some modification by the Competent Authority i.e. MoH&FW on 16.07.2018. Thereafter, a Committee for determination of compensation formula was constituted vide order dated 30.08.2018. Subsequently, a decision was also taken to make the report with modifications subject to which it had been accepted which is available in public domain. Accordingly, the report was uploaded on the website of CDSCO and the url as on date was referred. The Appellant, if so desires, may download a copy from the url (as mentioned in the written submission). In case, he requires a printed copy, the same can be made available on payment of Rs. 242/- through the prescribed mode. However, a copy of the report as desired by the Appellant in his RTI application was provided free of cost, to the Appellant during the hearing, the receipt of which was acknowledged by him.
Besides this, the Respondent handed over a copy of chronological sequence of events and further amendments on ASR issue as reiterated under:-
Page 2 of 7 Articular Surface Replacement (ASR) hip implants were manufactured by M/s. DePuy International Limited, U.K. (M/S Johnson & Johnson Pvt. Ltd.). ASR Hip Implants manufactured by M/s. DePuy International Limited, U.K were approved by DCG (I) in the year 2006 for import and marketing in the Country. The firm informed the CDSCO of their decision to voluntarily recall ASR on 24.08.2010. First recall was made in Australia in December 2009. Recall was also done in USA, Canada, UK, Brazil in August 2010.
CDSCO thereafter cancelled the import and marketing permission of the product on 11.07.2012 in public interest.
Several complaints were filed by Shri Vijay Vojhala with this Ministry and the O/o DCG (I).
After examination of the complaint, an expert committee was constituted by this Ministry vide order dated 08.02.2017 under the Chairmanship of Dr. Arun Kumar Agarwal, Ex-Dean and Professor of ENT, Maulana Azad Medical College, New Delhi to examine the issues relating to faulty ASR Hip Implants manufactured by M/s. DePuy International Limited, U.K. The Committee, after detailed examination of the issue, had submitted its report along with its final recommendation.
The report was accepted by the Central Government with slight modification with the approval of Hon'ble HFM.
As per accepted recommendations of the report, a Central Expert Committee under the Chairmanship of Dr. R.K. Arya, Director, Sports Injury Centre to determine the quantum of compensation was formed.
All the State/UT Governments had also been requested to form State Level Committee. All the State/ UT Government had also been requested to bring out advertisements in newspapers so that people may approach either of Central Expert Committee or State Level Committee.
Almost all the States have formed State Level Committees. Dr. R. K. Arya, Chairman, Central Expert Committee after holding five meetings prepared a formula for determining compensation for the affected ASR patients and forwarded to this Ministry vide letter dated 24.10.2018. The formula prepared by the Central Expert Committee was accepted by this Ministry on 29.11.2018.
The formula was placed in public domain through a Press Release on 29.11.2018. Dr. R. K. Arya vide letter dated 24.12.2018 was requested to give audience to the affected patients / their representatives / any other stakeholders and examine their inputs/ views and after examining the inputs, if deemed appropriate, to make recommendations to the Ministry for due consideration.
Shri Arun Kumar Goenka filed a Writ Petition (Civil) No. 1085/2018 in the Hon'ble Supreme Court of India. The Hon'ble Court vide order dated 11.01.2019 has disposed of the Writ Petition with directions which inter-alia included wide publicity in newspaper. Accordingly, an advertisement was published in 117 newspapers including vernacular editions of the local newspapers, across the Country.
04 compensation orders for making payment to patients have been passed by DCG (I) so far based on the approved formula.
M/s Johnson & Johnson filed a case in the Hon'ble High Court of Delhi against the compensation formula formulated by Arya Committee.
Page 3 of 7 Hon'ble High Court on 02.05.2019 directed that Rs. 25 lakhs should be paid by the company as compensation as accepted by it.
Hon'ble High Court of Delhi vide order dated 30.05.2019 mentioned that the petitioner i.e. M/s Johnson & Johnson was provided a list of 289 claimants by CDSCO out of which the CDSCO had verified 93 claimants.
The Johnson & Johnson further examined the same and found that out of the said list of persons; only 67 persons had undergone a revision surgery. In this connection, the Hon'ble Court has directed M/s Johnson & Johnson to deliver the cheques to the said claimants within a period of two weeks.
The case was listed on 08.08.2019 for hearing. However, the case could not be taken up by the Hon'ble Court due to paucity of time and on instructions, it was likely to be listed on 15.10.2019 for hearing.
CDSCO asked M/s Johnson & Johnson to provide the updated status for 154 patients for the payment of compensation provided to the ASR Hip Implant patients. In response, the M/s Johnson & Johnson has provided following information:
Out of the total of 154 patients, a total of 127 patients have received their compensation as on date as informed by Johnson & Johnson. We find that 13 patients are ineligible for compensation. We have asked kin of 4 deceased patients to provide us required documentation to process their cheques. We have processed the paper of 1 patient & who will be paid shortly. We are still following up with 9 patients for relevant documents.
CDSCO further handed over a list of 35 claimants to representative of Johnson & Johnson on 05.09.2019 for the payment of 25 lakhs rupees.
Further, the Order dated 30.08.2018 has also been modified by which patients who have undergone revision surgery before 2006 are also eligible for consideration of the compensation.
The aforesaid developments were not in the knowledge of the Appellant. The Respondent however maintained its earlier submissions and stated that a suitable response as per the provisions of the RTI Act, 2005, had already been provided to the Appellant.
The Commission was in receipt of a written submission from the Respondent, CDSCO (RTI Cell), dated 15.11.2019, wherein it was submitted that the RTI application/Appeal of the Applicant was forwarded to the MoH&FW, under Section 6(3) of the RTI Act, 2005. Moreover, the CPIO, MoH&FW had submitted the written submission dated 13.11.2019 a copy of which was enclosed.
The Commission referred to the definition of information u/s 2(f) of the RTI Act, 2005 which is reproduced below:
"information" means any material in any form, including records, documents, memos, e- mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, report, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force."
Furthermore, a reference can also be made to the relevant extract of Section 2 (j) of the RTI Act, 2005 which reads as under:
Page 4 of 7"(j) right to information" means the right to information accessible under this Act which is held by or under the control of any public authority and includes ........"
In this context a reference was made to the Hon'ble Supreme Court decision in 2011 (8) SCC 497 (CBSE Vs. Aditya Bandopadhyay), wherein it was held as under:
35..... "It is also not required to provide 'advice' or 'opinion' to an applicant, nor required to obtain and furnish any 'opinion' or 'advice' to an applicant. The reference to 'opinion' or 'advice' in the definition of 'information' in section 2(f) of the Act, only refers to such material available in the records of the public authority. Many public authorities have, as a public relation exercise, provide advice, guidance and opinion to the citizens. But that is purely voluntary and should not be confused with any obligation under the RTI Act."
Furthermore, the Hon'ble Supreme Court of India in Khanapuram Gandaiah Vs. Administrative Officer and Ors. Special Leave Petition (Civil) No.34868 OF 2009 (Decided on January 4, 2010) had held as under:
6. "....Under the RTI Act "information" is defined under Section 2(f) which provides:
"information" means any material in any form, including records, documents, memos, e- mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, report, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force."
This definition shows that an applicant under Section 6 of the RTI Act can get any information which is already in existence and accessible to the public authority under law. Of course, under the RTI Act an applicant is entitled to get copy of the opinions, advices, circulars, orders, etc., but he cannot ask for any information as to why such opinions, advices, circulars, orders, etc. have been passed."
7. "....the Public Information Officer is not supposed to have any material which is not before him; or any information he could have obtained under law. Under Section 6 of the RTI Act, an applicant is entitled to get only such information which can be accessed by the "public authority" under any other law for the time being in force. The answers sought by the petitioner in the application could not have been with the public authority nor could he have had access to this information and Respondent No. 4 was not obliged to give any reasons as to why he had taken such a decision in the matter which was before him."
With regard to larger public interest involved in the matter, the Commission referred to the decision of the Hon'ble Supreme Court in the matter of Bihar Public Service Commission v. Saiyed Hussain Abbas Rizwi: (2012) 13 SCC 61 wherein while explaining the term "Public Interest" it was held as under:
"22. The expression "public interest" has to be understood in its true connotation so as to give complete meaning to the relevant provisions of the Act. The expression "public interest" must be viewed in its strict sense with all its exceptions so as to justify denial of a statutory exemption in terms of the Act. In its common parlance, the expression "public interest", like "public purpose", is not capable of any precise definition. It does not have a rigid meaning, is elastic and takes its colour from the statute in which it occurs, the Page 5 of 7 concept varying with time and state of society and its needs (State of Bihar v. Kameshwar Singh([AIR 1952 SC 252]). It also means the general welfare of the public that warrants recognition and protection; something in which the public as a whole has a stake [Black's Law Dictionary (8th Edn.)]."
Furthermore, the Hon'ble Supreme Court in the matter of Ashok Kumar Pandey vs The State Of West Bengal (decided on 18 November, 2003Writ Petition (crl.) 199 of 2003) had made reference to the following texts for defining the meaning of "public interest':
"Strouds Judicial Dictionary, Volume 4 (IV Edition),'Public Interest' is defined thus:
"Public Interest (1) a matter of public or general interest does not mean that which is interesting as gratifying curiosity or a love of information or amusement but that in which a class of the community have a pecuniary interest, or some interest by which their legal rights or liabilities are affected."
In Black's Law Dictionary (Sixth Edition), "public interest" is defined as follows :
Public Interest something in which the public, or some interest by which their legal rights or liabilities are affected. It does not mean anything the particular localities, which may be affected by the matters in question. Interest shared by national government...."
In Mardia Chemical Limited v. Union of India (2004) 4 SCC 311, the Hon'ble Supreme Court of India while considering the validity of SARFAESI Act and recovery of non-performing assets by banks and financial institutions in India, recognised the significance of Public Interest and had held as under :
".............Public interest has always been considered to be above the private interest. Interest of an individual may, to some extent, be affected but it cannot have the potential of taking over the public interest having an impact in the socio-economic drive of the country..........."
Every action of a Public Authority is expected to be carried out in Public Interest. The Hon'ble Supreme Court of India in the matter of Kumari Shrilekha Vidyarthi, etc vs. State of UP and Ors., 1990 SCR Supl. (1) 625 dated 20.09.1990 wherein it had been held as under:
"Private parties are concerned only with their personal interest whereas the State while exercising its powers and discharging its functions, acts indubitably, as is expected of it, for public good and in public interest. The impact of every State action is also on public interest."
Similarly, the Hon'ble Supreme Court of India in the matter of LIC of India vs. Consumer Education and Research Centre, AIR 1995 SC 1811 dated 10.05.1995 had held as under:
"Every action of the public authority or the person acting in public interest or its acts give rise to public element, should be guided by public interest. It is the exercise of the public power or action hedged with public element becomes open to challenge."Page 6 of 7
DECISION:
Keeping in view the facts of the case and the submissions made by both the parties, the Commission noted that the requisite information as sought by the Appellant in his RTI application had been provided to him but the updated status in an important public interest matter had not been shared with the Appellant. Therefore, the Commission directs the Respondent to furnish the updated status to the Appellant within a period of 15 days from the date of receipt of this order.
The Appeal stands disposed accordingly.
(Bimal Julka) (िबमल जु का) (Information Commissioner) (सूचना आयु ) Authenticated true copy (अ भ मा णत स या पत त) (K.L. Das) (के .एल.दास) (Dy. Registrar) (उप-पंजीयक) 011-26182598/ [email protected] दनांक / Date: 25.11.2019 Copy to:-
1. The Secretary, Ministry of Health and Family Welfare, 'A' Wing, Nirman Bhawan, New Delhi-110011.Page 7 of 7